- +24 years experience in Quality management in the pharmaceutical
and biotech industry.
- Strong background in radiochemistry, organic and analytical chemistry
- Expertise in Internal Auditing, Method Validations and CMC preparation
- Excellent working knowledge with different Quality Systems and FDA Guidance
(i.e. ISO 9001, ISO 14001, 21 CFR 210-212)
- Familiar with aseptic manipulations, sterility testing and microbial examination
following USP<71>, <51>, <61> and <62>